FDA Adverse Event
Injury
Summary report: N
SUBTALAR M.B.A.
MDR report key: 443958
·
Received February 14, 2003
Report
- Report Number
- 2028840-2003-00011
- Event Type
- Injury
- Date Received
- February 14, 2003
- Date of Event
- February 7, 2003
- Report Date
- February 13, 2003
- Manufacturer
- KINETIKOS MEDICAL, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON FEB 12, 2003, KMI WAS NOTIFIED OF THE EXPLANT OF A SIZE 10MM SUBTALAR M.B.A. TO ADDRESS PAIN REPORTED BY THE PATIENT. THE PRIMARY SURGEON INDICATED THE DEVICE WAS AN INCORRECT SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALAR M.B.A. | ORTHOPAEDIC FOOT IMPLANT | HRS | KINETIKOS MEDICAL, INC. | 05-0110 | 7688-7786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other |